Hyperandrogenism in women is a hormonal imbalance which results in excess testosterone and/or reduced estrogen receptor effects caused by polycystic ovarian syndrome (PCOS), primary functional hyperandrogenism (FAH), congenital adrenal hyperplasia (CAH), aromatase deficiency, ovarian hyperthecosis, adrenal hyperandrogenism (excess adrenal production of DHEA, DHEA sulfate, and androstenedione) and exogenous dehydroepiandrosterone (DHEA) intake. Hyperandrogenism in women causes acne, hirsutism, weight gain, alopecia, irregular menstrual bleeding, insulin resistance, cardiovascular disease, endometrial cancer, and non-alcoholic fatty liver disease.
The most disfiguring effects of hyperandrogenism in women is cystic acne. Scars from cystic acne are left both physically and emotionally. Current treatment for cystic acne caused by hyperandrogenism is exogenous hormones (hormonal contraceptives), oral antibiotics, oral retinoid, and up until just a couple months ago, anti-androgen medications were used. Anti-androgen medications little effect on reducing acne in women, and have side effects that range from hepatotoxicity, carcinogenesis, anemia, heart failure, renal failure, depression, and some are altogether contraindicated in women of childbearing age. Oral retinoid medications have a high propensity for even more devastating side effects to include hepatitis, glomerulonephritis, inflammatory bowel disease, pancreatitis, pseudotumor cerebri, vision impairment, hearing impairment, tinnitus, dyslipidemia, hyperglycemia, depression, psychosis, and aggressive or violent behavior. Both of these treatments have side effects that are dangerous, and they are also less effective than treatment with paroxetine and myo-inositol.
Hormonal contraceptives are typically used, but these medications increase cardiovascular risk, increase risk of breast cancer, weight gain, and can even exacerbate acne. With weight gain there is increased adipose tissue. Increased adipose tissue decreases sex hormone-binding globulin (SHBG) which increases circulating unbound androgens, and makes acne worse. Oral antibiotics are also used; however, oral antibiotics can cause bacterial resistance, hepatic impairment, renal impairment, hearing loss, QT prolongation (the measure of delayed ventricular repolarization), and autoimmune disorders such as Lupus when used for a long period of time.
The present invention reduces the symptoms caused by hyperandrogensim for female patients. The present invention reduces testosterone levels and increasing estrogen and insulin sensitivity, therefore reducing the symptoms cystic acne, hirsutism, weight, alopecia, irregular menstrual bleeding, insulin resistance, dyslipidemia, and non-alcoholic fatty liver disease.